Mylan Announces Tentative Approval for Ondansetron Hydrochloride Tablets
Posted on: Friday, 26 August 2005, 15:01 CDT
PITTSBURGH, Aug. 26 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride Tablets, 4 mg, 8 mg, 16 mg, and 24 mg. Ondansetron HCl Tablets are the generic version of GlaxoSmithKline's Zofran(R) Tablets, which had annual sales of approximately $600 million, based on IMS data, for the 12 month period ended June 30, 2005.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories, Inc., that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.
For more information about Mylan, visit http://www.mylan.com/.
Mylan Laboratories Inc.
CONTACT: Patrick Fitzgerald or Kris King, of Mylan Laboratories Inc.,+1-724-514-1800
Web site: http://www.mylan.com/
Source: PRNewswire-FirstCall
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